Institute of General Practice, Goethe University Frankfurt am Main; Pharmacy of University Hospital Frankfurt; Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum; Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum; Institute of General Practice, Goethe University Frankfurt am Main; Working Group General and Family Medicine, Medical Faculty East Westphalia-Lippe, University of Bielefeld; Institute of General Practice, Goethe University Frankfurt am Main; Bergisch Competence Center for Health Economics and Health Services Research, Bergische University Wuppertal; Chair of General Medicine II and Patient Orientation in Primary Care, Institute of General Medicine and Ambulatory Health Care (iamag), University Witten/Herdecke; Working Group for Health Economics and Health Management, Faculty of ; Health Sciences, Bielefeld University; Chairman of the Drug Therapy Management and Drug Therapy Safety Commission, German Society for Internal Medicine (DGIM); Barmer, Wuppertal; Institute of Clinical Pharmacology, University Hospital and Faculty of Medicine, Goethe University Frankfurt, Frankfurt am Main; Institute for Evidence-Based Healthcare, Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Queensland, 4229, Australia; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK; PMV Research Group, Faculty of Medicine, University Hospital Cologne, University of Cologne; Institute of General Practice, Goethe-University Frankfurt am Main; Department of Family Medicine, Care and Public Health Research Institute, Maastricht University; Department of Public Health and Primary Care, Academic Centre of General Practice, KU Leuven.
Dtsch Arztebl Int. 2024 Apr 19;121(8):243-250. doi: 10.3238/arztebl.m2024.0007.
Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality.
This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention- to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects.
688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]).
The planned analyses did not reveal any significant effect of the intervention. Pandemicadjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.
对于同时服用多种药物的患者，不适当的药物处方可能会产生可避免的不良后果。我们研究了药物管理临床决策支持系统（CDSS）对住院和死亡率的影响。
这是一项在德国威斯特伐利亚-利珀的初级保健实践（= 集群）中进行的、采用 stepped-wedge、cluster-randomized、controlled 试验，涉及一个开放性的同时服用多种药物的成年患者队列。在干预期间，每年使用 CDSS 检查他们的药物清单。CDSS 根据患者相关的健康保险数据对不适当的处方提出警告。主要复合终点包括全因死亡率和因任何原因住院。次要终点为死亡率、住院率和高危处方。我们使用混合逻辑模型对意向治疗人群的季度健康保险数据进行分析，该模型考虑了聚类和重复测量。敏感性分析涉及 COVID-19 大流行的影响和其他影响。
共有 688 个初级保健实践被随机分配，共获得了 42700 名患者在 391994 个季度的健康保险数据。主要终点（比值比 [OR] 1.00；95%置信区间 [0.95；1.04]；p = 0.8716）或次要终点（住院：OR 1.00 [0.95；1.05]；死亡率：OR 1.04 [0.92；1.17]；高危处方：OR 0.98 [0.92；1.04]）均未发现显著降低。
计划的分析未发现干预的任何显著效果。经过大流行调整的分析表明，CDSS 可能潜在地降低同时服用多种药物的成年患者的死亡率。需要进行具有适当随访的对照试验，以证明 CDSS 对同时服用多种药物的患者的死亡率有显著影响。
